Last Updated: April 30, 2026

Details for New Drug Application (NDA): 202191

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NDA 202191 describes METOCLOPRAMIDE HYDROCHLORIDE, which is a drug marketed by Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Chartwell Molecular, Genus, Morton Grove, Paco, Pharmobedient Cnsltg, Roxane, Teva, Vistapharm Llc, Novel Labs Inc, Aiping Pharm Inc, Chartwell Rx, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Sandoz, Schering, Strides Pharma Intl, Sun Pharm Industries, Superpharm, Usl Pharma, and Watson Labs, and is included in fifty-three NDAs. It is available from thirty-two suppliers. Additional details are available on the METOCLOPRAMIDE HYDROCHLORIDE profile page.

The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for 202191

Tradename:	METOCLOPRAMIDE HYDROCHLORIDE
Applicant:	Novel Labs Inc
Ingredient:	metoclopramide hydrochloride
Patents:	0

Pharmacology for NDA: 202191

Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 202191

Antiemetics
Dopamine D2 Receptor Antagonists

Suppliers and Packaging for NDA: 202191

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202191	ANDA	Lupin Pharmaceuticals,Inc.	43386-580	43386-580-31	1 BLISTER PACK in 1 CARTON (43386-580-31) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202191	ANDA	Lupin Pharmaceuticals,Inc.	43386-581	43386-581-31	1 BLISTER PACK in 1 CARTON (43386-581-31) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 5MG BASE
Approval Date:	Aug 15, 2014	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 10MG BASE
Approval Date:	Aug 15, 2014	TE:		RLD:	No

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